Prevention of Oral Mucositis After Using Oral Topical Vitamin E Versus Voriconazole and Levofloxacin in Pediatric Cancer Patients Receiving Chemotherapy

NCT03613389 | Unknown

• 1 other identifier: CEBD-CU-2018-06-20
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Statement of problem Oral mucositis is an inflammatory condition that affects mucosa of the oral cavity. The etiology of this kind of aggravation is related to the introduction of radiotherapy or chemotherapeutic medications. (Alvarino et al., 2014, Rohani et al., 2015) With the prevalence of mucositis up to 80% in pediatric patient (Cheng et al., 2004). Clinically, oral mucositis is a painful situation that significantly affects patients' quality of life. The severe cases are associated with ulcerated mucosa and secondary infection which may led to life-threatening sepsis. (Kolokythas , et al., 2010) Oral mucositis is one of the most debilitating complications following chemotherapy, its remains an unresolved clinical problem, and it has physical and psychosocial implications for patients. The ulcerative lesions are often very painful, requiring treatment with analgesics and supportive nutrition, and the cancer treatment may need to be interrupted or modified. All these conditions may increase treatment costs, preclude further treatment and alter the quality of life of the patient. (Sonis et al., 2001) There are many oral care regimens including prophylactic antibacterial and antifungal drugs, Levofloxacin is antibacterial drug causing inhibition of cell wall synthesis agent, Levofloxacin failed to show any significant difference in mucositis or oral ulceration (Bucaneve et al., 2005). While voriconazole is antifungal that has been noted to cause transient visual disturbances and A major drawback is potential interactions with certain chemotherapy agents (Marks et al., 2011). Vitamin E is an antioxidant agent which may limit tissue damage from free oxygen radicals and, thus, may reduce the severity of mucositis during cancer treatments and protect cell membranes from radiation damage (Alterio et al., 2007). It has a very low toxicity and is generally well-tolerated (Geeraert et al., 2015). Rationale There is no enough studies about vitamin E effect in reduction of oral mucositis. El -Housseiny et al., (2007), recommend that oral mucositis is successfully treated by the topical application of vitamin "E", compared to its systemic administration. Vitamin "E" alone is not enough for the treatment of infected lesions; further studies using vitamin "E" to treat the infected lesions are needed. Also based on the recommendation of Wadleigh et al., (1992) who was the first one to study the topical effect of vitamin "E" on oral mucositis; however, they did not know whether the effect was due to the topical application or the systemic absorption of the vitamin when applied topically. Benefit to patient and population: The vitamin E is nontoxic, odorless, tasteless, and well tolerated by the patients, reduce nutritional compromise, maintain impact on quality of life, and reasonable economic costs. Benefits of practitioners and clinicians: The use of vitamin E is easy to apply, not technique sensitive and it is cheap and readily available reducing clinical time.

Conditions

Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy

Outcome Measures

Primary Outcomes (1)

• Clinical assessment of Oral Mucositis

  Oral mucositis WHO Toxicity Scale (Paula Elaine et al., 2016)will be ranked according to WHO classification criteria (Appendix B): * Grade 0: No change. * Grade 1: Soreness/erythema. • Grade 2: Erythema, and Ulcers; patient can eat solids. • Grade 3: Ulcers; the patient requires liquid diet only. • Grade 4: Oral nourishment is not possible.

  5 days

Study Arms (2)

oral topical vitamin E

EXPERIMENTAL

Dietary Supplement: oral topical vitamin E

voriconazole and levofloxacin

NO INTERVENTION

Interventions

oral topical vitamin E DIETARY_SUPPLEMENT

Vitamin E is an antioxidant agent which may limit tissue damage from free oxygen radicals and, thus, may reduce the severity of mucositis during cancer treatments and protect cell membranes from radiation damage (Alterio et al., 2007). It has a very low toxicity and is generally well-tolerated (Geeraert et al., 2015).

oral topical vitamin E

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All children fulfilling the following criteria will be included:
• Patients with healthy and intact oral mucosa.
• Patients diagnosed with Acute Myeloid leukemias for the first time or during consolidation cycle.
• Both male and female patients undergoing chemotherapy at in and Out patient units of Pediatric Oncology department.
• Age of patient ranging (6- 18) years old.
• Legal representatives of patient must be able to read, understand and provide informed consent to participate in the trial.
• Patients with no history of dental discomfort related to cold or hot food or beverage intake.
• Patients receiving chemotherapeutic regimen known to cause oral mucositis (e.g. Cytarabine and Etoposide).

You may not qualify if:

• Administration of antiviral or antifungal therapy and/or any other treatment for oral mucositis before enrollment in the study.
• Presence of advanced or severe periodontitis (pocket depth more than 6mm).
• Patients who are scheduled for radiotherapy as part of their treatment.

Sponsors & Collaborators

• Cairo University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Samah Omer Mekki

Cairo, 0020, Egypt

Location

MeSH Terms

Conditions

Stomatitis; Ulcer

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S, Faculty of Dentistry, Khartoum College of Medical Sciences, Sudan (2011)

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 3, 2018
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: September 1, 2020
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

EG (1)